MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX BR ANCHOR W/OC&ND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on an unknown date, it was observed that the anchor device broke when transferred to the implant and could not be removed.Another hole was punched to implant another like device.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that the doctor used 5.5awl to ream the hole and punched 5.5 healix br, but it was broken when transferred to the implant and could not remove all the remaining body, so he had to punch another hole and then successfully implanted the 5.5 healix br anchor.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photos were provided.Upon visual inspection of the photos, it was observed that the anchor was broken, and it was not in place.Also, the suture card was not attached in the device.Finally, it was found blood residues along the anchor.The other photo showed an x-ray image of the remaining body of the anchor near the joint.The complaint can be confirmed.The possible root cause can be associated with off axis insertion and levering during insertion.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number:6l47501, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 5.5 HEALIX BR ANCHOR W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10836791
• Report Number: 1221934-2020-03470
• Device Sequence Number: 4012034
• Product Code: MAI
• UDI-Device Identifier: 10886705007783
• UDI-Public: 10886705007783
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 222232
• Device Catalogue Number: 222232
• Device Lot Number: 6L47501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/13/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention